In this Quarterly Report on Form 10-Q (this “Quarterly Report”) references to “we,” “our,” “us,” the “Company” or “Palatin” mean Palatin Technologies, Inc. and its subsidiary.
Statements in this Quarterly Report, as well as oral statements that may be made by us or by our officers, directors, or employees acting on our behalf, that are not historical facts constitute “forward-looking statements,” which are made pursuant to the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The forward-looking statements in this Quarterly Report do not constitute guarantees of future performance. Investors are cautioned that statements that are not strictly historical facts contained in this Quarterly Report, including, without limitation, the following are forward-looking statements:
| ● | our ability to obtain additional financing on terms acceptable to us, or at all, including unavailability of funds or delays in receiving funds as a result of economic disruptions; |
| ● | our expectation that we will incur losses for the foreseeable future and may never achieve or maintain profitability; |
| ● | our business, financial condition, and results of operations may be adversely affected by increases in costs of and delays in conducting human clinical trials and the performance of our contractors and suppliers, reduction in our productivity or the productivity of our contractors and suppliers, supply chain constraints, and labor shortages; |
| ● | whether Boehringer Ingelheim International GmbH (“Boehringer Ingelheim”), which in August 2025 acquired certain Palatin intellectual property to first-in-class melanocortin receptor-targeted compounds developed by Palatin, will be able to successfully develop a product for the treatment of retinal diseases; |
| ● | the results of further development, clinical trials and the timing of regulatory submissions with our obesity program, including a novel once-weekly peptide melanocortin receptor-4 (“MC4R) selective agonist with an Investigational New Drug (“IND”) filing projected in the fourth quarter of calendar year 2026 and an oral small molecule MC4R selective agonist with an IND filing projected in the first half of calendar year 2027; PL8177, an oral peptide MC1R formulation for treatment of ulcerative colitis, which reported positive topline data in a Phase 2 clinical trial proof-of-concept trial in the first quarter of 2025; and an MCR agonist for diabetic nephropathy, which reported positive topline data in the fourth quarter of 2024; |
| ● | estimates of our expenses, future revenue and capital requirements; |
| ● | our ability to achieve profitability; |
| ● | the initiation, timing, progress and results of future preclinical studies and clinical trials, and our research and development programs; |
| ● | our expectations regarding the clinical efficacy and utility of our melanocortin agonist product candidates for treatment of inflammatory and autoimmune related diseases and disorders, including ocular indications; |
| ● | our ability to compete with other products and technologies treating the same or similar indications as our product candidates; |
| ● | the ability of our contract manufacturers to perform their manufacturing activities for us in compliance with applicable regulations; |
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| ● | our ability to recognize the potential value of our licensing arrangements with third parties; |
| ● | the potential to achieve revenues from the sale of our product candidates; |
| ● | our ability to obtain adequate reimbursement from private insurers and other healthcare payers; |
| ● | our ability to maintain product liability insurance at a reasonable cost or in sufficient amounts, if at all; |
| ● | the performance and retention of our management team, senior staff professionals, other employees, and third-party contractors and consultants; |
| ● | the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology in the United States and throughout the world; |
| ● | our compliance with federal and state laws and regulations; |
| ● | the timing and costs associated with obtaining regulatory approval for our product candidates; |
| ● | the impact of fluctuations in foreign exchange rates; |
| ● | the impact of any geopolitical instability, economic uncertainty, financial markets volatility, or capital markets disruption resulting from the ongoing military conflict between Russia and Ukraine or conflicts in the Middle East, and any resulting effects on our revenue, financial condition, or results of operations; |
| ● | the impact of legislative or regulatory healthcare reforms in the United States; |
| ● | our ability to adapt to changes in global economic conditions as well as competing products and technologies; and |
| ● | our ability to remain listed on the NYSE American stock exchange. |
Such forward-looking statements involve risks, uncertainties and other factors that could cause our actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. Our future operating results are subject to risks and uncertainties and are dependent upon many factors, including, without limitation, the risks identified under the caption “Risk Factors” and elsewhere in this Quarterly Report, and any of those made in our other reports filed with the U.S. Securities and Exchange Commission (the “SEC”). Except as required by law, we do not intend, and undertake no obligation, to publicly update forward-looking statements to reflect events or circumstances after the date of this document or to reflect the occurrence of unanticipated events.
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